Antimicrobial wipe

ABSTRACT

A nonwoven wipe comprises an antiseptic solution comprising a bis-(dihydropyridinyl)-decane derivative, a first fiber having a denier of about 1.5 to about 2.0, and a second fiber having a denier of about 3.0 to 3.5. About 30 wt % to 70 wt % of the total weight of the nonwoven wipe is the first fiber and about 30 wt % to 70 wt % of the total weight of the nonwoven wipe is the second fiber. The bis-(dihydropyridinyl)-decane may be octenidine dihydrochloride.

CROSS-REFERENCE TO RELATED APPLICATION

This Application for Patent is a Continuation of U.S. patent applicationSer. No. 14/985,042, titled “ANTIMICROBIAL WIPE”, filed on Dec. 30,2015, the entire contents of which are incorporated by reference herein.

FIELD OF THE INVENTION

Aspects of the present invention relate to the field antimicrobialwipes, and in particular a non-woven wipe soaked with an antisepticsolution.

BACKGROUND OF THE INVENTION

U.S. Pat. No. 7,427,574 to Allen discloses a non-woven washcloth formedfrom a blend of two different size polyester fibers, the majority ofwhich have a length about half of that of the minority. The washclothdisclosed by Allen is particularly designed to have absorbing andholding properties for a non-alcoholic solution containing chlorhexidinegluconate (CHG), while also releasing the CHG when wiped on skin. Asnoted by Allen, a problem with CHG and CHG blends is that they tend tochemically or mechanically bind with certain fibers. Thus, Allendiscloses a particular washcloth for use with CHG that purports to avoidsuch problems.

The washcloth of Allen being specially designed for a non-alcoholic CHGsolution is not disclosed as suitable for use with other antisepticsolutions. Molecules other than CHG may be more potent and have otheradvantages over CHG.

U.S. Pat. No. 7,066,916 to Keaty, Jr. discloses a method of treating apatient prior to surgery using a cloth wipe soaked with a non-alcoholicCHG solution.

Thus, there is a need in the art for a wipe comprising an antisepticsolution having a more potent antiseptic.

SUMMARY OF THE INVENTION

Aspects of the present invention overcome the above identified problems,as well as others, by providing a wipe comprising an antiseptic solutioncomprising a bis-(dihydropyridinyl)-decane derivative, a first fiberhaving a denier of about 1.5 to about 2.0, and a second fiber having adenier of about 3.0 to 3.5. About 30 wt % to 70 wt % of the total weightof the wipe may be the first fiber and about 30 wt % to 70 wt % of thetotal weight of the wipe may be the second fiber. Thebis-(dihydropyridinyl)-decane may be octenidine dihydrochloride.

The wipe may include a third fiber having a denier of about 5.0 to 6.0,wherein about 10 wt % to about 30 wt % of the total weight of the wipeis the third fiber. In an example aspect, about 40 wt % of the totalnumber of fibers is the first fiber, about 40 wt % of the total weightof the wipe is the second fiber, and about 20 wt % of the total weightof the wipe is the third fiber. Each of the first, second, and thirdfiber may comprise polyester.

Aspects of the present invention include a package containing the wipe.The package may comprise a metal foil or a metalized plastic. The wipemay be sterilized by expositing the package containing the wipe to atemperature of about 110 to 130° C. for at time of about 15 to 30minutes.

The package may further include a warming mechanism. The warmingmechanism may comprise reactants that create an exothermic reaction whenexposed to ambient air or when exposed to each other.

Additional advantages and novel features relating to aspects of thepresent invention will be set forth in part in the description thatfollows, and in part will become more apparent to those skilled in theart upon examination of the following or upon learning by practicethereof.

DETAILED DESCRIPTION

Various aspects of a wipe may be illustrated with reference to one ormore exemplary embodiments. As used herein, the term “exemplary” means“serving as an example, instance, or illustration,” and should notnecessarily be construed as preferred or advantageous over otherembodiments.

The term “about” as used herein preferably means±5% and more preferably±1% of the provided value.

Aspects of the present invention include a wipe comprising an antisepticsolution. In an aspect of the present invention, the antiseptic solutionis aqueous. That is, the solvent of the solution is primarily water. Asused herein, aqueous means at least about 50% v/v or more water, morepreferably at least about 60% v/v or more water, more preferably atleast about 70% v/v or more water, more preferably at least about 80%v/v or more water, more preferably at least about 90% v/v or more water,more preferably at least about 95% v/v or more water, up to 100% v/vwater. When the solution is less than 100% v/v water, the remainingvolume may include one or more additional solvents, for example,alcoholic solvents. Example alcoholic solvents include ethanol,isopropanol, and n-propanol. For example, the solution may contain lessthan about 50% v/v, more preferably less than about 40% v/v, morepreferably less than about 30% v/v, more preferably less than about 20%v/v, more preferably less than about 10% v/v, down to 0% v/v alcohol.

In another aspect of the present invention, the antiseptic solution isalcoholic, where the above solvent is primarily alcohol. When thesolvent primarily comprises alcohol, there may be about 50% v/v or morealcohol, more preferably about 60% v/v or more alcohol, more preferablyabout 70% v/v or more alcohol, more preferably about 80% v/v or morealcohol, more preferably 90% v/v or more alcohol, more preferably about95% v/v or more alcohol. When the solution comprises less than 100% v/valcohol, the remaining volume may include one or more additionalsolvents, for example, water. Example alcoholic solvents includeethanol, isopropanol, and n-propanol. For example, the solution maycontain less than about 50% v/v, more preferably less than about 40%v/v, more preferably less than about 30% v/v, more preferably less thanabout 20% v/v, more preferably less than about 10% v/v, down to 0% v/vwater.

Suitable antiseptic molecules include bis-(dihydropyridinyl)-decanederivatives. As used herein, the term “derivative” refers to a) achemical substance that is related structurally to a first chemicalsubstance and derivable from it; b) a compound that is formed from asimilar first compound or a compound that can be imagined to arise fromanother first compound, if one atom of the first compound is replacedwith another atom or group of atoms; c) a compound derived or obtainedfrom a parent compound and containing essential elements of the parentcompound; or d) a chemical compound that may be produced from firstcompound of similar structure in one or more steps. Preferred antisepticagents include octenidine salts, such as octenidine dihydrochloride. Theconcentration of antiseptic molecule (e.g., octenidine dihydrochloride)may be from about 0.01% w/v to about 5.0% w/v, more preferably about0.1% w/v to about 3.0% w/v, more preferably from about 0.2% w/v to about1.0% w/v, and still more preferably from about 0.3% w/v to about 0.6%w/v. In one example aspect, the concentration of antiseptic molecule(e.g., octenidine dihydrochloride) may be 0.4% w/v. In another example,the concentration of antiseptic molecule (e.g., octenidinedihydrochloride) may be above 0.2% w/v. In an aspect of the presentinvention the bis-(dihydropyridinyl)-decane derivative (e.g., octenidinedihydrochloride) may be the only antimicrobial molecule present in thesolution. In another aspect to of the present invention, the solutionmay include more than one antiseptic, for example, the solution mayinclude a mixture of a bis-(dihydropyridinyl)-decane derivative (e.g.,octenidine dihydrochloride) and a biguanide (e.g., chlorhexidinegluconate). In one example aspect the solution may include 2.0% w/v orless of a biguanide (e.g., chlorhexidine gluconate) and 1.0% w/v or lessof a bis-(dihydropyridinyl)-decane derivative (e.g., octenidinedihydrochloride).

The wipe may contain additional components to enhance the effectivenessof the antiseptic solution when applied to a surface (e.g., human skin)via the wipe. For example, the wipe may contain non-activeingredients/agents with functions that include skin conditioning (e.g.,moisturizing and skin smoothing), visualization, solubility, stability,viscosity, wetting, preservatives, etc. In an aspect of the presentinvention, the wipe may comprise one or more, including all, of thefollowing additional components: from about 0.2% w/v to about 8.0% w/v,more preferably from about 2.0% w/v to about 5.0% w/v of a skinconditioner, from about 0.1% w/v to about 15% w/v, more preferably about5.0% w/v to about 10.0% w/v of a preservative such as isopropyl alcohol,ethanol, and/or n-proponal, from about 0.01% w/v to about 3.0% w/v, morepreferably about 0.05% w/v to about 2.0% w/v, and more preferably about0.1% w/v to about 1.0% w/v of a antifoaming agent such as dimethicone(polydimethylsiloxane) e.g., dimethicone 350 cst, from about 0.1% w/v toabout 5.0% w/v, more preferably about 0.5% w/v to about 3.0% w/v of asurfactant such as polyoxyl 40 hydrogenated castor oil, also known asmacrogol-glycerolhydroxystearate (e.g., Cremophor® RH40; Kolliphor™ RH40, each sold by BASF), about 0.01% w/v to about 0.2% w/v, morepreferably from about 0.05% w/v to about 0.125% w/v of a surfactant suchas nonoxynol-9 (α-(p-Nonylphenyl)-ω-hydroxynona(oxyethylene)), and fromabout 0.1% w/v to about 1.5% w/v, more preferably 0.5% w/v to about 1.0%w/v pH buffer salts.

In an aspect of the present invention, one or more of the above-listedcomponents may be entirely omitted. For example, in one example aspectall alcohol may be omitted, i.e., no alcohol as solvent and no alcoholas a preservative.

The skin conditioner may comprise one or more compounds, for exampleabout 0.1% w/v to about 5.0% w/v (relative to the overall solution),more preferably about 0.1% w/v to about 3.0% w/v of glycerin and about0.1% w/v to about 3.0% w/v (relative to the overall solution), morepreferably about 1.0% w/v to about 2.0% w/v of 1,3-propanediol. Thebuffer salts may comprise one or more buffer salts, to provide a desiredsolution overall pH. The buffer salts and concentrations of buffer saltsmay be chosen such that the solution has a pH of 4 to 7, more preferably5.5 to 7, for example 6. Example buffer salts include monobasicpotassium phosphate and dibasic sodium phosphate, and combinationsthereof. As an alternative to polyoxyl 40 hydrogenated castor oil,polysorbate 20 (polyoxyethylene 20 sorbitan monolaurate), 60, and/or 80may be used. The above components can be contained in the antisepticsolution. Alternatively, these above components can be added separatelyto the wipe.

The wipe to which the antiseptic solution and, optionally the additionalcomponents, may be applied, may be a non-woven fabric formed from aplurality of different polymer fibers. In an aspect of the presentinvention, the wipe may comprise two or more, more preferably threedifferent polymer fiber types. In one example aspect the wipe comprisesor consists of two different types of fibers and in another exampleaspect the wipe comprises or consists of three different types offibers. The wipe may be formed using known nonwoven fabric manufacturingtechniques. One such general process includes first defining the finaldensity of the desired wipe (e.g., the grams per square meter (gsm) ofthe completed wipe), second homogenously blending the fibers together ina predetermined ratio including relative amounts sufficient to providethe defined density, third carding the blended fibers, fourthcross-lapping the carded fibers, and fifth needle punching thecross-lapped fibers. The needle punching serves as a method ofmechanical entanglement of the blended fibers. Other suitablemechanical/thermal engagement methods known in the relevant art may alsobe used. As is known in the relevant art, needle punching involvespunching fine barbed needles into the cross-lapped fibers whichgenerally entangles fibers on the bottom of the cross-lapped fibers withfibers at the top. This technique of needle punching reduces theoccurrence of pilling and linting in the completed nonwoven material.

In one example aspect of the present invention, the first type of fibermay be a polyester fiber having a denier of about 1.3 to about 2.0, morepreferably 1.5, and the second type of fiber may be a polyester fiberhaving a denier of about 2.5 to about 3.5, more preferably 3.0. Thelength of both the first and second fiber types may be about 1.0 to 4.0inches, more preferably 3.0 inches. About 30 wt % to about 70 wt %, morepreferably about 40 wt % to about 50 wt % of the wipe may be the firstfiber type. About 30 wt % to 70 wt %, more preferably about 40 wt % toabout 50 wt % of the wipe may be the second fiber type. As noted above,in an aspect of the present invention, the wipe may consist only ofthese two fiber types. The polyester may comprise polyethyleneterephthalate, which is sold for example under the brand name Dacron®.

As used herein, wt % means the weight of the particular fiber relativeto the total weight of the final wipe material prior to soaking withsolution. For example, if a given wipe material is 160 grams per squaremeter (gsm), and is 50 wt % of the first fiber and 50 wt % of the secondfiber, then 80 gsm is attributable to the first fiber and 80 gsm isattributable to the second fiber.

In another aspect of the present invention, the wipe may include a thirdtype of fiber in addition to the first and second fiber types. The thirdtype of fiber may be a polyester fiber having a denier of about 5.0 toabout 7.0 denier, more preferably 6.0 denier. Having the third fiber of5.0 to about 7.0, more preferably 6.0 denier provides additionalexfoliating properties to the wipe. Adding exfoliation propertiesincreases the efficacy of the wipe by removing dead skin when it isbeing used to wipe the skin. The length of the third fiber type may alsohave a length of about 1.0 to about 4.0 inches, more preferably 3.0inches. About 10 wt % to about 30 wt %, more preferably about 15 wt % toabout 25 wt % of the wipe may be the third fiber type, in addition tothe relative amounts of the first and second fiber types noted above. Inan aspect of the present invention, the wipe may consist only of thethree fiber types, in which case the relative amounts of the first,second, and third fiber types would be selected so that the totalpercentage of type one, type two, and type three together are 100 wt %.For example, 40 wt % of the wipe may be the first type, 40 wt % of thewipe may be the second type, and 20 wt % of the total number of fibersin the wipe may the third type.

The completed wipe may have a thickness of about 0.070 inches to about0.110 inches, more preferably about 0.080 inches to about 0.100 inches,and more preferably about 0.085 inches to about 0.095 inches. Thedensity may be about 130 grams per square meter (gsm) to about 175 gsm,more preferably about 140 gsm to about 165 gsm, and more preferablyabout 145 gsm to about 160 gsm. The wipe can be cut to a desired sizedepending on the use. For example, the wipe may be cut to an 8.0 inch by8.0 inch square.

An 8.0 inch by 8.0 inch wipe having the above properties and comprisingthe above fibers was found to absorb about 20 to about 30 mL of theabove-described antiseptic solution, with 25 mL being preferable. Thewipe may absorb from about 0.3 mL of solution per square inch of wipe toabout 0.4 mL of solution per square inch of wipe. The solution may beapplied to the wipe by spraying the solution on the wipe, dipping thewipe into the solution or pouring the solution over the wipe until it issaturated, with spraying being preferred.

Once soaked with solution, the wipe may then be packaged. The packagemay be made of a material that sufficiently conducts heat whilemaintaining integrity to allow the wipe to be sterilized by heatsterilization when the package is exposed to a heat sterilizationprocess. For example, the package material may be a metal foil (e.g.,aluminum foil) or a metalized plastic (e.g., a metalized polyethyleneterephthalate film). The thickness of the package material may be about0.002 inches to 0.010 inches.

It has been found that when the above-described wipe is soaked with theabove-described solution, and then the soaked wipe is applied to skin,the solution is released from the wipe and remains effective as anantimicrobial. Examples and experimental results are discussed below.

Once packaged, the wipe can be sterilized by exposing the entire packageto a heat sterilization process. The heat sterilization process includesexposing the package with the wipe to a predetermined temperature (i.e.,a sterilization temperature) for a predetermined period of time (i.e., asterilization time). In an aspect of the present invention, the packagecan be exposed to a sterilization temperature from about 110° C. toabout 135° C., more preferably 115° C. to about 130° C., and morepreferably about 120° C. to about 125° C. For example, the sterilizationtemperature may be 121° C. The package may be exposed to the temperaturefor a time period of about 15 minutes to about 35 minutes, morepreferably about 20 minutes to about 30 minutes. For example, thesterilization time may be 24 minutes. During the sterilization process,an overpressure may be applied sufficient to maintain the seal on thepackage and maintain the antiseptic solution in liquid form. Forexample, an overpressure of 2-3 bar may be used.

After sterilization, the antiseptic solution remains in the wipe and theantiseptic molecule remains sufficiently pure to maintain antimicrobialefficacy due in part to the stability of octenidine dihydrochloride. Asused herein, purity means the percent concentration of antisepticmolecules in solution relative to the total concentration of antisepticmolecules plus concentration of substances that are derived from orrelated to the antiseptic molecule. For example, a 95% pure antisepticsolution means that if there are 100 molecules that are eitherantiseptic molecules or molecules derived from or related to theantiseptic molecule, 95 of the molecules are the antiseptic molecule and5 of those molecules are derived from or related to the antisepticmolecule. These molecules derived from or relating to the antisepticmolecule have reduced or no antimicrobial activity. Thus, a lower puritysolution will have lower antimicrobial efficacy as fewer of the targetantiseptic molecules are delivered to the patient's skin. Further, alower purity solution will not comply with regulatory requirements. Bymeasuring the concentration of antiseptic molecules in solution ascompared to concentration of antiseptic molecules and molecules derivedfrom or related to the antiseptic molecule, one can determine the purityof the solution. The solution in the wipe following sterilization may beat least 95% pure, more preferably at least 96% pure, more preferably atleast 97% pure, more preferably at least 98% pure, more preferably atleast 99% pure, and most preferably 99.5% pure. In other words, thepercent of impurities derived from the antiseptic molecule (e.g.,octenidine dihydrochloride) relative to total number of impurities plusantiseptic molecules may be 5% or less, more preferably 4% or less, morepreferably 3% or less, more preferably 2% or less, more preferably 1% orless, and most preferably 0.5% or less.

It is believed that by heating the antiseptic solution contained in thewipe to the above sterilization temperatures and maintaining thetemperature for the above sterilization times, sufficiently sterilizesthe solution, while maintaining sufficient antimicrobial efficacy. Theamount of degradation of the antiseptic molecule can be quantified bymeasuring the initial purity of antiseptic solution prior to thesterilization process and measuring the post-sterilized purity ofantiseptic solution after the sterilization process. Thus, as usedherein, the “initial purity” is the purity prior to sterilization and“post-sterilization purity” is the purity of the solution aftersterilization once the wipe has reached room temperature.

Octenidine dihydrochloride molecules may degrade into one or more of thefollowing molecules when heat treated:N,N′-(decane-1(pyridine-1-yl-4-ylidene)octan-1-amine)-10,(4-hydroxypyridine) (IUPAC name:1-{10-[4-(Octylimino)-1H-pyrid-1-yl]decyl}-1H-pyridin-4-one; molecularformula: C₂₈H₄₅N₃O; Formula I) anddecane-1(pyridine-1-yl-4-ylindene)octan-1-amine)-10-ol (IUPAC name:10-[4-(Octylimino)-1H-pyrid-1-yl]decanol; molecular formula: C₂₃H₄₂N₂O;Formula II).

Thus, the purity of the solution can be determined by comparing theamount of octenidine dihydrochloride molecules to all of theabove-listed octenidine dihydrochloride related substances. However, itshould be noted that the above list is not exhaustive. One havingordinary skill in the art would be able to determine which molecules aredegradants of the antiseptic molecule after the sterilization process.

The combination of sterilization temperature and sterilization time maybe chosen such that the percentage point change in purity from theinitial purity to the post-sterilization purity is at most about 5%,more preferably at most about 3%, more preferably at most about 2%, andmost preferably at most about 1%. It should be understood that thepercentage point change refers to the absolute percentage pointdifference between the initial purity and the post-sterilization purity.For example, a change in initial purity of 95% to a post-sterilizationpurity of 90% is a percentage point change of 5%.

It is within the scope of the invention that any machine capable ofheating the wipe with antiseptic solution to the sterilizationtemperature and maintaining the wipe with solution at the sterilizationtemperature for the sterilization time may be used. Example equipmentmay include a water bath, oil bath, autoclave, convection oven,cascading water sterilizer, and the like. A cascading water sterilizerprovides a constant stream of water which heats the solution to thesterilization temperature, maintains the sterilization temperature overthe entirety of the sterilization time, and finally cools the solution.

In another aspect of the present invention, it is desirable for the wipeto be heated to a comfortable temperature just prior to use on apatient. This can be achieved in a variety of ways. In one example, thepractitioner can place the package with wipes into a separate warmingdevice, such as an electrically powered warming cabinet. The metalizedplastic package can also be heated in a microwave. More preferably,however, to avoid the need for a separate warming device, the packagecontaining the wipe may include (internally or externally) a warmingmechanism that provides an on-demand exothermic (chemical or physical)reaction. The exothermic reaction produces heat to warm the wipe withoutreacting with or otherwise affecting the antiseptic solution. Forexample the portable heater described in U.S. Pat. App. Pub. No.2010/0146849 comprises a particulate composite fuel that reacts withoxygen in the air to produce heat, a thermal conductive member, and aninsulating member. Other suitable warming mechanisms are described inU.S. Pat. App. Pub. Nos. 2010/0163011, 2010/0326418, 2013/0174835,2014/0102435, 2014/01809889, 2014/0109890. Each of the precedingdocuments is expressly incorporated by reference herein in theirentirety.

In an aspect of the present invention, any of the above noted warmingmechanisms may be specifically tailored so that the user can initiatethe reaction by removing a strip, cover, or sticker which exposes one ormore reactants to the ambient environment. Alternatively, the user mayexpose one or more reactants which are all contained in the package toeach other to initiate the heat-generating reaction, without exposingthe reactants to ambient environment. Other examples of reactioninitiators may include turning a dial, pressing a button, snapping orbreaking a reaction initiator, and/or physical manipulation of thepackage (e.g. folding, shaking, squeezing, or twisting). In these casesthe wipe is heated before the package is opened. Alternatively, thereaction may be initiated by the process of opening the package itself.The reaction may be particularly tailored such that the wipes reach atemperature of about 100° F. to about 125° F. within about 1 to about 2minutes. Preferably, the reaction may be tailored to reach 125° F.within 1 minute. Alternatively, the user may choose the desired finaltemperature by activating a specific section of the package to initiatevarying degrees of the exothermic reaction. For example, a first finaltemperature could be obtained by removal of one strip, while a secondfinal temperature could be obtained by removal of a second strip. Tothis end, other mechanisms mentioned above for initiation of theexothermic reaction could be similarly modified to allow varying degreesof heating or choice between discrete final temperatures.

EXAMPLES Example 1

A wipe was prepared using a blend of a first polyester fiber having adenier of 1.5 and a length of 1.5 inches and a second polyester fiberhaving a denier of 3.0 and a length of 3.0 inches. 50 wt % of the wipewas the first polyester fiber and 50 wt % of the wipe was the secondpolyester fiber. The wipe was prepared using the manufacturing methoddescribed above including needle punching. The amount of each fiber wasloaded per square meter to provide a completed wipe density of 160 gsm.Thus, 80 gsm of the wipe weight was attributed to the first fiber and 80gsm of the wipe weight was attributed to the second fiber. The producedwipe had a thickness of 0.090 inches. The wipe was soaked with anantiseptic solution. The solution contained 0.4% w/v octenidinedihydrochloride, 1.5% w/v glycerin, 1.5% w/v 1,3-propanediol, 0.0875%w/v dimethicone, 0.50% w/v polysorbate 20, 0.06% w/v Nonoxynol-9, 0.62%w/v Monobasic Potassium Phosphate, 0.07% w/v salt Dibasic SodiumPhosphate, and the remainder water. The wipe absorbed 25 mL of solution.

Example 2

The same wipe of Example 1 was prepared. The wipe was soaked with anantiseptic solution. The solution contained 0.4% w/v octenidinedihydrochloride, 1.5% w/v glycerin, 1.5% w/v 1,3-propanediol, 0.0875%w/v dimethicone, 0.125% w/v Nonoxynol-9, 0.50% w/v Cremophor® RH40,0.62% w/v pH 6 buffer slat Monobasic Potassium Phosphate, 0.07% w/v pH 6buffer salt Dibasic Sodium Phosphate, and the remainder water. The wipeabsorbed 25 mL of solution.

Example 3

A wipe was prepared using a blend of a first polyester fiber having adenier of 1.5 and a length of 3.0 inches and a second polyester fiberhaving a denier of 3.0 and a length of 3.0 inches. 50 wt % of the wipewas the first polyester fiber and 50 wt % of the wipe was the secondpolyester fiber. The same manufacturing method of Example 1 was usedexcept that the degree of needle punching was increased so that theamount of mechanical entanglement in wipe was increased by 25% ascompared to the wipe of Example 1. The resulting wipe has the samerelative amount of fibers as Example 1 but had a thickness of 0.085inches. The wipe was soaked with the same antiseptic solution of Example2.

Example 4

The same wipe of Example 3 was prepared. The wipe was soaked with thesame antiseptic solution of Example 1.

Example 5

The same wipe of Example 3 was prepared. The wipe was soaked with asolution containing 0.4% w/v octenidine dihydrochloride, 1.5% w/vglycerin, 1.5% w/v 1,3-propanediol, 0.0875% w/v dimethicone, 0.125% w/vNonoxynol-9, 0.50% w/v polysorbate 20, 0.62% w/v pH 6 buffer slatMonobasic Potassium Phosphate, 0.07% w/v pH 6 buffer salt Dibasic SodiumPhosphate, and the remainder water.

Comparative Example 6

A wipe having 2% w/v chlorhexidine gluconate solution soaked therein wasobtained from Sage Product Inc., having National Drug Code (NDC) number53462-705-23.

Example 7

A wipe was prepared using a blend of a first polyester fiber having adenier of 1.5 and a length of 1.5 inches, a second polyester fiberhaving a denier of 3.0 and a length of 3.0 inches, and a third polyesterfiber having a denier of 6.0 and a length of 3.0 inches. 40 wt % of thewipe was the first polyester fiber, 40 wt % of the wipe was the secondpolyester fiber, and 20 wt % of wipe was the third polyester fiber. Thewipe was prepared using the manufacturing method described aboveincluding needle punching. The amount of each fiber was loaded persquare meter to provide a completed wipe density of 160 gsm. Thus, 64gsm of the wipe weight was attributed to the first fiber and 64 gsm ofthe wipe weight was attributed to the second fiber, and 32 gsm wasattributed to the third fiber. The produced wipe has a thickness of0.090 inches. The same antiseptic solution of Example 1 was soaked intothe wipe.

Example 8

A wipe was prepared using a blend of a first polyester fiber having adenier of 1.5 and a length of 3.0 inches, a second polyester fiberhaving a denier of 3.0 and a length of 3.0 inches, and a third polyesterfiber having a denier of 6.0 and a length of 3.0 inches. 40 wt % of thewipe was the first polyester fiber, 40 wt % of the wipe was the secondpolyester fiber, and 20 wt % of wipe was the third polyester fiber. Thewipe was manufactured the same as Example 7, except that the degree ofneedle punching was increased so that the amount of mechanicalentanglement in wipe was increased by 25% as compared to the wipe ofExample 7. The resulting wipe had a thickness of 0.085 inches. The wipewas soaked with the same antiseptic solution of Example 1.

Example 9

The same wipe of Example 7 was prepared. The wipe was soaked with thesolution of Example 2.

Example 10

The same wipe of Example 8 was prepared. The wipe was soaked with thesolution of Example 2.

Example 11

A wipe was prepared using a blend of a first polyester fiber having adenier of 1.5 and a length of 1.5 inches and a second polyester fiberhaving a denier of 3.0 and a length of 3.0 inches. 50 wt % of the wipewas the first polyester fiber and 50 wt % of the wipe was the secondpolyester fiber. The wipe was prepared using the manufacturing methoddescribed above including needle punching. The amount of each fiber wasloaded per square meter to provide a completed wipe density of 145 gsm.Thus, 72.5 gsm of the wipe weight was attributed to the first fiber and72.5 gsm of the wipe weight was attributed to the second fiber. Theproduced wipe had a thickness of 0.085 inches. The same antisepticsolution of Example 1 was soaked into the wipe.

Example 12

A wipe was prepared using a blend of a first polyester fiber having adenier of 1.5 and a length of 1.5 inches, a second polyester fiberhaving a denier of 3.0 and a length of 3.0 inches, and a third polyesterfiber having a denier of 6.0 and a length of 3.0 inches. 40 wt % of thewipe was the first polyester fiber, 40 wt % of the wipe was the secondpolyester fiber, and 20 wt % of wipe was the third polyester fiber. Thewipe was prepared using the manufacturing method described aboveincluding needle punching. The amount of each fiber was loaded persquare meter to provide a completed wipe density of 145 gsm. Thus, 58gsm of the wipe weight was attributed to the first fiber and 58 gsm ofthe wipe weight was attributed to the second fiber, and 29 gsm wasattributed to the third fiber. The produced wipe has a thickness of0.085 inches. The same antiseptic solution of Example 1 was soaked intothe wipe.

Comparative Example P1

The same wipe of Example 3 was prepared. The wipe was soaked with asolution containing 1.5% w/v glycerin, 1.5% w/v 1,3-propanediol, 0.0875%w/v dimethicone, 0.06% w/v Nonoxynol-9, 0.50% w/v polysorbate 20, 0.62%w/v pH 6 buffer slat Monobasic Potassium Phosphate, 0.07% w/v pH 6buffer salt Dibasic Sodium Phosphate, and the remainder water. Notably,no antiseptic was included.

Example P2

The same wipe of Example 3 was prepared. The wipe was soaked with asolution containing 0.4% w/v octenidine dihydrochloride, 1.5% w/vglycerin, 1.5% w/v 1,3-propanediol, 0.0875% w/v dimethicone, 0.06% w/vNonoxynol-9, 0.50% w/v polysorbate 20, 0.62% w/v pH 6 buffer slatMonobasic Potassium Phosphate, 0.07% w/v pH 6 buffer salt Dibasic SodiumPhosphate, and the remainder water

Example P3

The same wipe of Example 3 was prepared. The wipe was soaked with asolution containing 0.4% w/v octenidine dihydrochloride, 1.5% w/vglycerin, 1.5% w/v 1,3-propanediol, 0.0875% w/v dimethicone, 0.06% w/vNonoxynol-9, 0.50% w/v Cremophor® RH-40, 0.62% w/v pH 6 buffer slatMonobasic Potassium Phosphate, 0.07% w/v pH 6 buffer salt Dibasic SodiumPhosphate, and the remainder water.

D-Value Determination

The D-value for a microorganism is the time required to reduce itspopulation by 90% at a specified temperature and substrate condition,and the value is used in the art to establish a sterilization time. Thusafter a colony is reduced by 1 D, only 10% of the original organismsremain, i.e., the population number has been reduced by one decimalplace in the counting scheme. D-values can be calculated using theSurvivor Curve Method described in ISO 11138-1:2006, Annex C.

A 4.0 inch×4.0 inch polyester wipe of Example 1 was soaked with 6 mL ofan antiseptic solution consisting of 0.4% w/v octenidine dihydrochloridedissolved in water and innocluated with approximately 10⁷ colony-formingunits (CFU) of Geobacillus stearothermophilus spores. The soaked samplewas enclosed in an aluminum foil pouch and heat sealed. The pouch wasthen exposed to 121° C. heat for 5.0, 10.0 and 15.0 minutes in a steamvessel. The above steps were duplicated four times for each exposuretime. Four samples were also tested that were not exposed to the heat.

A population assay was performed on the wipes. The Colony Forming Unit(CFU) counts from population assays performed on exposed and unexposedwipes are presented in Tables 1 through 4.

TABLE 1 Exposure Time (minutes) 0.0 (#1) 0.0 (#2) 0.0 (#3) 0.0 (#4)Dilution CFU Count CFU Count CFU Count CFU Count 10⁻⁴ TNTC TNTC TNTCTNTC TNTC TNTC TNTC TNTC 10⁻⁵ 42 35 46 40 34 51 55 43

TABLE 2 Exposure Time (minutes) 5.0 (#1) 5.0 (#2) 5.0 (#3) 5.0 (#4)Dilution CFU Count CFU Count CFU Count CFU Count 10⁻² 4 6 5 3 5 3 2 410⁻³ 3 2 2 1 2 1 0 0 10⁻⁴ 0 0 0 0 0 0 0 0 10⁻⁵ 0 0 0 0 0 0 0 0

TABLE 3 Exposure Time (minutes) 10.0 (#1) 10.0 (#2) 10.0 (#3) 10.0 (#4)Dilution CFU Count CFU Count CFU Count CFU Count 10⁻² 1 1 1 1 0 0 0 010⁻³ 0 0 0 0 0 0 0 0 10⁻⁴ 0 0 0 0 0 0 0 0

TABLE 4 Exposure Time (minutes) 15.0 (#1) 15.0 (#2) 15.0 (#3) 15.0 (#4)Dilution CFU Count CFU Count CFU Count CFU Count 10⁻² 0 0 0 0 0 0 0 010⁻³ 0 0 0 0 0 0 0 0

Using the CFU count data presented in Tables 1-4, the population of G.stearothermophilus spores in the exposed and unexposed units ofinoculated polyester wipes was calculated. Based on the averagepopulation determined from each exposure time, a survivor curvefollowing the Survivor Curve Method was created and a D₁₂₁-value of 2.0minutes was calculated based on a survivor curve with an r² of 0.9269.

The above process may also be used to find the D value for othersterilization temperatures.

Antimicrobial Efficacy

Examples P1-P3 and 6 were tested for antimicrobial efficacy. For eachexample, five 7″×7″ sections of pig skin were prepared and eachdelineated with a 5″×5″ treatment and evaluation area. Each of the pigskin sections was inoculated with a known population of Staphylococcusepidermidis and allowed to dry at 36.1° C.-36.2° C., with a relativehumidity of 90%-92% for 30 minutes. After drying, each inoculatedsection was sampled using standard cup scrub methodology to measure thebaseline. After the baseline, the examples were applied to each of theinoculated sections using a back and forth motion for 3-minutes (eachwipe was turned over and re-folded after 1 minute 30 seconds) andallowed to dry for 1-minute. After contact times of 30 seconds and 10minutes post-prep, a specific area was sampled in the same manner as thebaseline. Each sample was serially diluted and selected aliquots wereplated. All plates were incubated at 36±1° C. for 48±2 hours. Theresults are shown in the below tables.

TABLE 5 Example P3 Log₁₀ Average Log₁₀ Reduc- CFU CFU/ CFU/ tion/Replicate Sample per mL cm²* cm² cm² 1 Baseline 1.7 × 10⁵ 2.7 × 10⁵ 5.43NA 30 seconds 1.5 × 10² 2.4 × 10² 2.38 3.05 10 minutes 5.4 × 10² 8.5 ×10² 2.93 2.50 2 Baseline 1.2 × 10⁵ 1.9 × 10⁵ 5.28 NA 30 seconds 1.2 ×10³ 1.9 × 10³ 3.28 2.00 10 minutes 1.4 × 10² 2.2 × 10² 2.34 2.94 3Baseline 8.6 × 10⁴ 1.4 × 10⁵ 5.15 NA 30 seconds 8.5 × 10² 1.3 × 10³ 3.112.04 10 minutes 3.5 × 10² 5.5 × 10² 2.74 2.41 4 Baseline 1.3 × 10⁵ 2.1 ×10⁵ 5.32 NA 30 seconds 6.2 × 10² 9.8 × 10² 2.99 2.33 10 minutes 2.0 ×10² 3.2 × 10² 2.51 2.81 5 Baseline 1.7 × 10⁵ 2.7 × 10⁵ 5.43 NA 30seconds 7.7 × 10¹ 1.2 × 10² 2.08 3.35 10 minutes 1.8 × 10¹ 2.8 × 10¹1.45 3.98

TABLE 6 Example P2 Log₁₀ Average Log₁₀ Reduc- CFU CFU/ CFU/ tion/Replicate Sample per mL cm²* cm² cm² 1 Baseline 2.1 × 10⁵ 3.3 × 10⁵ 5.52NA 30 seconds 1.6 × 10² 2.5 × 10² 2.40 3.12 10 minutes 2.1 × 10¹ 3.3 ×10¹ 1.51 4.01 2 Baseline 1.6 × 10⁵ 2.5 × 10⁵ 5.40 NA 30 seconds 1.5 ×10³ 2.4 × 10³ 3.38 2.02 10 minutes 8.0 × 10¹ 1.3 × 10² 2.11 3.29 3Baseline 1.5 × 10⁵ 2.4 × 10⁵ 5.38 NA 30 seconds 5.7 × 10² 9.0 × 10² 2.952.43 10 minutes 1.4 × 10² 2.2 × 10² 2.34 3.04 4 Baseline 7.9 × 10⁴ 1.2 ×10⁵ 5.08 NA 30 seconds 3.5 × 10² 5.5 × 10² 2.74 2.34 10 minutes 1.9 ×10² 3.0 × 10² 2.48 2.60 5 Baseline 1.7 × 10⁵ 2.7 × 10⁵ 5.43 NA 30seconds 4.7 × 10¹ 7.4 × 10¹ 1.87 3.56 10 minutes 1.4 × 10¹ 2.2 × 10¹1.34 4.09

TABLE 7 Comparative Example P1 Log₁₀ Average Log₁₀ Reduc- CFU CFU/ CFU/tion/ Replicate Sample per mL cm²* cm² cm² 1 Baseline 2.1 × 10⁵ 3.3 ×10⁵ 5.52 NA 30 seconds 1.1 × 10⁴ 1.7 × 10⁴ 4.23 1.29 10 minutes 1.2 ×10⁴ 1.9 × 10⁴ 4.28 1.24 2 Baseline 2.3 × 10⁵ 3.6 × 10⁵ 5.56 NA 30seconds 3.2 × 10⁴ 5.1 × 10⁴ 4.71 0.85 10 minutes 5.8 × 10³ 9.2 × 10³3.96 1.60 3 Baseline 1.7 × 10⁵ 2.7 × 10⁵ 5.43 NA 30 seconds 8.2 × 10³1.3 × 10⁴ 4.11 1.32 10 minutes 1.3 × 10⁴ 2.1 × 10⁴ 4.32 1.11 4 Baseline1.7 × 10⁵ 2.7 × 10⁵ 5.43 NA 30 seconds 1.3 × 10⁴ 2.1 × 10⁴ 4.32 1.11 10minutes 1.8 × 10⁴ 2.8 × 10⁴ 4.45 0.98 5 Baseline 1.1 × 10⁵ 1.7 × 10⁵5.23 NA 30 seconds 3.9 × 10³ 6.2 × 10³ 3.79 1.44 10 minutes 3.3 × 10³5.2 × 10³ 3.72 1.51

TABLE 8 Comparative Example 6 Log₁₀ Average Log₁₀ Reduc- CFU CFU/ CFU/tion/ Replicate Sample per mL cm²* cm² cm² 1 Baseline 1.6 × 10⁵ 2.5 ×10⁵ 5.40 NA 30 seconds 1.2 × 10³ 1.9 × 10³ 3.28 2.12 10 minutes 8.6 ×10² 1.4 × 10³ 3.15 2.25 2 Baseline 1.6 × 10⁵ 2.5 × 10⁵ 5.40 NA 30seconds 5.3 × 10² 8.4 × 10² 2.92 2.48 10 minutes 4.6 × 10¹ 7.3 × 10¹1.86 3.54 3 Baseline 1.6 × 10⁵ 2.5 × 10⁵ 5.40 NA 30 seconds 3.2 × 10²5.1 × 10² 2.71 2.69 10 minutes 1.4 × 10² 2.2 × 10² 2.34 3.06 4 Baseline1.9 × 10⁵ 3.0 × 10⁵ 5.48 NA 30 seconds 9.8 × 10² 1.5 × 10³ 3.18 2.30 10minutes 7.9 × 10² 1.2 × 10³ 3.08 2.40 5 Baseline 9.6 × 10⁴ 1.5 × 10⁵5.18 NA 30 seconds 2.7 × 10¹ 4.3 × 10¹ 1.63 3.55 10 minutes 1.6 × 10¹2.5 × 10¹ 1.40 3.78

TABLE 9 30 Seconds Contact Time Log₁₀ Reduction Average Log₁₀ TestArticle per Replicate Reduction Example P3 Replicate 1 3.05 2.55Replicate 2 2.00 Replicate 3 2.04 Replicate 4 2.33 Replicate 5 3.35Example P2 Replicate 1 3.12 2.69 Replicate 2 2.02 Replicate 3 2.43Replicate 4 2.34 Replicate 5 3.56 Comparative Replicate 1 1.29 1.20Example P1 Replicate 2 0.85 Replicate 3 1.32 Replicate 4 1.11 Replicate5 1.44 Comparative Replicate 1 2.12 2.63 Example 6 Replicate 2 2.48Replicate 3 2.69 Replicate 4 2.30 Replicate 5 3.55

TABLE 10 10 Minutes Contact Time Log₁₀ Reduction Average Log₁₀ TestArticle per Replicate Reduction Example P3 Replicate 1 2.50 2.93Replicate 2 2.94 Replicate 3 2.41 Replicate 4 2.81 Replicate 5 3.98Example P2 Replicate 1 4.01 3.41 Replicate 2 3.29 Replicate 3 3.04Replicate 4 2.60 Replicate 5 4.09 Comparative Replicate 1 1.24 1.29Example P1 Replicate 2 1.60 Replicate 3 1.11 Replicate 4 0.98 Replicate5 1.51 Comparative Replicate 1 2.25 3.01 Example 6 Replicate 2 3.54Replicate 3 3.06 Replicate 4 2.40 Replicate 5 3.78

As shown from the above data, the CFU/cm² recovered from theartificially contaminated pig skin substrate using Staphylococcusepidermidis, Example P3, Example P2 and Comparative Example 6 achievedat least a 2.5 log reduction at the 30 second and 10 minute samplingtime points. The CFU/cm² recovered from the artificially contaminatedpig skin substrate using Staphylococcus epidermidis, Comparative ExampleP1 did not meet the proposed 2.5 log reduction at the 30 second and 10minute sampling time points.

Octenidine dihydrochloride is a cationic antimicrobial agent with potentmicrobicidal activity against a broad range of microorganisms. However,being cationic in nature, octenidine dihydrochloride has a tendency tointeract with anionic or nonionic surfactants (surface active agents)significantly decreasing its potency. Surface active agents may be addedto antiseptic and cleaning products to provide hygiene benefits and toaid in the overall microbicidal effect of a product. The solutions usedin wipes may contain multiple excipients that can potentially interactwith octenidine dihydrochloride resulting in reduced efficacy.

Multiple surfactants in solution formulations were tested for use withthe wipes. Effects of individual excipients such as phosphate buffer,polysorbate 20, nonoxynol-9, Cremophor® RH-40, dimethicone, andcombinations of these products were investigated to determine thepossibility of adverse effects on the antimicrobial efficacy ofoctenidine dihydrochloride. Bactericidal activities of octenidinedihydrochloride alone and in combinations with various excipients (Table11) were tested by a time kill method using Staphylococcus aureus ATCC29213 as test organism (Table 12).

TABLE 11 Compositions of formulations with Nonoxynol-9 and polysorbate20 Full base formulation with Nonoxynol-9 with Polysorbate 20 Glycerin1.50% 1.50% 1,3-Propanediol 1.50% 1.50% Dimethicone USP 0.05% 0.05%Polysorbate 20 0.50% 1.50% Nonoxynol-9 0.10%   0% Na₂HPO₄ 0.62% 0.62%KH₂PO₄ 0.06% 0.06% All percent values are w/v

TABLE 12 Effect of excipients on the potency of OctenidineDihydrochloride (OCT) OCT Base Formulation Conc. Log Standard or Vehicle(PPM) Reduction Deviation Water 2 3.41 0.15 20 3.78 0.15 100 4.65 0.21500 5.12 0.06 Phosphate Buffered Water, pH 6.0 2 1.39 0.16 20 2.87 0.28100 4.78 0.26 500 5.12 0.06 1.5% Polysorbate 20 in water 2 0.30 0.13 200.57 0.11 100 1.01 0.11 500 1.12 0.21 0.1% Nonoxynol-9 in water 2 1.520.19 20 2.94 0.12 100 4.69 0.32 500 5.12 0.06 0.25% Dimethicone in water2 1.17 0.11 20 1.41 0.11 100 1.67 0.13 500 2.12 0.07 Full baseformulation with 2 0.04 0.11 Polysorbate 20 20 0.35 0.12 100 0.49 0.14500 0.76 0.07 Full base formulation with 2 0.29 0.23 Nonoxynol-9 andPolysorbate 20 20 0.58 0.14 100 0.60 0.14 500 1.40 0.10 1000 3.94* 0.352000 4.14* 0.07 4000 4.14* 0.07 *Total kill was achieved; log reduction,calculated as the limit of detection, are reported.

As shown in Table 12, octenidine dihydrochloride alone, at aconcentration as low as 2 PPM and a contact time of 30 seconds, causedrapid loss in bacterial viability resulting in >99.9% reduction inviable count. Octenidine dihydrochloride dissolved in pH 6.0 phosphatebuffered water required >20 PPM (>10 times the concentration in water)to showed 99.9% reduction in viable count. Polysorbate 20, dimethiconeand nonoxynol-9 were found to have significant neutralizing effects onthe bactericidal activity of OCT up to a concentration of 500 PPM.However, higher than 1000 PPM of octenidine dihydrochloride in the fullbase formulation was found to be rapidly microbicidal. The “full baseformulation” is the formulation defined in Table 11.

Neutralizing effects of two similar surfactants, 0.5% Cremophor® RH40and 0.5% polysorbate 20, on the bactericidal activity of octenidinedihydrochloride were tested using the Staphylococcus aureus ATCC 29213as test organism (Table 13 and 14).

TABLE 13 Adverse effects of Cremophor ® RH40 and Polysorbate 20 onbactericidal activity of octenidine dihydrochloride OCT Average Conc.Average Log Standard Percent Formulation in PPM Log Reduction DeviationReduction Aqueous 20 2.000 5.123 0.066 99.999 100 2.000 5.123 0.06699.999 500 2.000 5.123 0.066 99.999 0.5% Cremophor ® RH40 20 6.383 0.7400.310 81.808 100 5.651 1.472 0.155 96.624 500 2.000 5.123 0.066 99.9990.5% Polysorbate 20 20 6.327 0.795 0.140 83.979 100 5.917 1.205 0.23693.767 500 4.043 3.080 0.116 99.917 Full base formulation with 40003.000 4.123 0.066 99.992 Cremophor ® RH40 (Table 11) Full baseformulation with 4000 3.000 4.123 0.066 99.992 Polysorbate 20 (Table 11)Baseline NA 7.123

TABLE 14 Compositions of full base formulations with Polysorbate 20 andCremphor ® RH40 With With Cremphor ® Polysorbate Full Base FormulationRH40 20 USP Purified Water or qs 100% qs 100% equivalent Glycerin, USP 1.50%  1.50% 1,3-propanediol, USP  1.50%  1.50% Dimethicone  0.05% 0.05% Polysorbate 20, USP  0.00%  0.50% Cremophor ® RH40  0.50%  0.00%Nonoxynol-9, USP  0.05%  0.05% pH 6 Buffer salt: Monobasic 0.618% 0.618%Potassium Phosphate, NF pH 6 Buffer salt: Dibasic 0.065% 0.065% SodiumPhosphate, USP

Although 0.5% Cremophor® RH40 appeared to be slightly less inhibitorythan 0.5% polysorbate 20, both agents required 500 PPM of octenidinedihydrochloride to deliver >3 log reduction in viable count within 30seconds of contact time.

The above data indicates that nonionic surfactants reduce the efficacyof octenidine dihydrochloride in a concentration dependent manner andconcentration of surfactants and octenidine dihydrochloride can bebalanced to provide desired efficacy of the formulated products. Forexample, polysorbate 20 (0.5% to 1.5%) may have >500 PPM of octenidinedihydrochloride to deliver rapid microbicidal efficacy.

Squeezing Volume

The squeezing volume of a wipe is a measure of the amount of antisepticsolution squeezed out from a soaked wipe. Wipes with high squeezingvolumes tend to deliver more volume when scrubbing is performed. It hasbeen found that the use of a bis-(dihydropyridinyl)-decane derivative(e.g., octenidine dihydrochloride) solution soaked into a polyester wipemay lower the squeezing volume, creating a undesirable feeling ofdryness on the wipe. It has been found that by increasing the surfactantconcentration in the solution, the squeezing volume of the wipe may beincreased. Furthermore, it has been unexpectedly found that unlikebiguanides (e.g., chlorohexidine gluconate), the addition of abis-(dihydropyridinyl)-decane derivative (e.g., octenidinedihydrochloride) and heat treatment significantly changes the wetnessfeeling of the wipe and less solution can be squeezed out from the wipe.

The squeezing volume has been evaluated on different wipes withdifferent formulations. The following formulations were prepared (in allof the below formulations the components are reported in terms of w/vbasis, which can be calculated from a v/v basis when the final densityof the formulation was determined):

Formulation 1 (F1)—0.4% w/v chlorhexidine digluconate and the remainderwater.

Formulation 2 (F2)—0.4% w/v chlorhexidine digluconate, 1.5% w/vglycerin, 1.5% w/v 1,3-propanediol, 0.5% w/v Dow Corning 365 35%Dimethicone NF Emulsion, 1.5% w/v polysorbate 20, and the remainderwater.

Formulation 3 (F3)—pure water.

Formulation 4 (F4)—0.4% w/v octenidine dihydrochloride and the remainderwater.

Formulation 5 (F5)—0.5% w/v Dow Corning 365 35% Dimethicone NF Emulsionand the remainder water.

Formulation 6 (F6)—0.4% w/v octenidine dihydrochloride, 0.5% w/v DowCorning 365 35% Dimethicone NF Emulsion, and the remainder water.

Formulation 7 (F7)—2.0% w/v glycerin, 2.0% w/v 1,3-propanediol, 0.5% w/vDow Corning 365 35% Dimethicone NF Emulsion, 0.5% w/v polysorbate 20,and the remainder water.

Formulation 8 (F8)—0.4% w/v octenidine dihydrochloride, 2.0% w/vglycerin, 2.0% w/v 1,3-propanediol, 0.5% w/v Dow Corning 365 35%Dimethicone NF Emulsion, 0.5% w/v polysorbate 20, and the remainderwater.

Formulation 9 (F9)—2.0% w/v glycerin, 2.0% w/v 1,3-propanediol, 1.0% w/vDow Corning 365 35% Dimethicone NF Emulsion, 1.0% w/v polysorbate 20,and the remainder water.

Formulation 10 (F10)—0.4% w/v octenidine dihydrochloride, 2.0% w/vglycerin, 2.0% w/v 1,3-propanediol, 1.0% w/v Dow Corning 365 35%Dimethicone NF Emulsion, 1.0% w/v polysorbate 20, and the remainderwater.

Formulation 11 (F11)—1.5% w/v glycerin, 1.5% w/v 1,3-propanediol, 0.57%w/v Dow Corning 365 35% Dimethicone NF Emulsion, 1.5% w/v polysorbate20, and the remainder water.

Formulation 12 (F12)—0.4% w/v octenidine dihydrochloride, 1.5% w/vglycerin, 1.5% w/v 1,3-propanediol, 0.57% w/v Dow Corning 365 35%Dimethicone NF Emulsion, 1.5% w/v polysorbate 20, and the remainderwater.

Formulation 13 (F13)—1.0% w/v glycerin, 1.50% w/v 1,3-propanediol, 0.14%w/v Dow Corning 365 35% Dimethicone NF Emulsion, 2.0% w/v polysorbate20, and the remainder water.

Formulation 14 (F14)—0.4% w/v octenidine dihydrochloride, 1.0% w/vglycerin, 1.50% w/v 1,3-propanediol, 0.14% w/v Dow Corning 365 35%Dimethicone NF Emulsion, 2.0% w/v polysorbate 20, and the remainderwater.

25 mL of each of Formulations 1-14 were individually applied to adifferent sample of the wipe of Example 8, i.e., producing 14 wipes eachsoaked with one of the formulations. Each of the soaked wipes wassqueezed until no more solution was observed to come out of the wipe.The mass of each wipe was recorded before and after squeezing to obtainthe squeezing volume, the results of which are reported below in Table15.

TABLE 15 Squeeze Volumes Soaked Formulation Squeeze Volume (g) F1 (noOCT present) 7.9 ± 1.2 F2 (no OCT present) 17 ± 1.4 F3 (no OCT present)14 ± 2.7 F4 (OCT present) 3.2 ± 1.3 F5 (no OCT present) 15.4 ± 0.9  F6(OCT present) 4 ± 1 F7 (no OCT present) 14.3 ± 1.5  F8 (OCT present) 5.7± 0.8 F9 (no OCT present) 16.5 ± 1.3  F10 (OCT present) 8.8 ± 1.6 F11(no OCT present) 19.1 ± 1.1  F12 (OCT present) 16.2 ± 0.3  F13 (no OCTpresent) 18.5 ± 1.1  F14 (OCT present) 16.2 ± 1.6 

Table 15 shows that the addition of octenidine dihydrochloride orchlorhexidine digluconate to water significantly lowered the squeezevolume delivered as compared to similar formulations lacking octenidinedihydrochloride and chlorhexidine digluconate. However, by increasingconcentration of surfactant polysorbate 20, the difference betweensqueezing volume delivered by the wet wipes with and without octenidinedihydrochloride is reduced. Wipes loaded with 2% polysorbate 20 (F14) or1.5% polysorbate 20 (F12) and 0.4% octenidine dihydrochloride deliveredno significant volume difference from wet wipes loaded with 1.5%polysorbate 20 and 0.4% chlorhexidine digluconate (F2).

The effect of heat sterilization on the squeezing volume of moistenedwipes has further been evaluated. The following formulations wereprepared:

Formula 15 (F15)—0.4% w/v Octenidine dihydrochloride, 1.5% w/v GlycerinUSP, 1.5% w/v 1,3 propanediol USP, 0.71% w/v Dow Corning 365 35%Dimethicone NF Emulsion, 1.0% w/v Kolliphor™ RH 40 (Polyoxyl 40hydrogenated castor oil), 0.125% w/v noxynol 9 USP, 0.62% w/v monobasicpotassium phosphate (KH₂PO₄), 0.06% w/v and dibasic sodium phosphate(Na₂HPO₄), and the remainder water.

Formula 16 (F16)—0.4% w/v Octenidine dihydrochloride, 1.5% w/v GlycerinUSP, 1.5% w/v 1,3 propanediol USP, 0.14% w/v Dow Corning 365 35%Dimethicone NF Emulsion, 0.5% w/v Kolliphor™ RH 40 (polyoxyl 40hydrogenated castor oil), 0.06% w/v noxynol 9 USP, 0.62% w/v monobasicpotassium phosphate (KH₂PO₄), 0.06% w/v dibasic sodium phosphate(Na₂HPO₄), and the remainder water.

8 inch by 8 inch wipes of Examples 1, 3, 7, 8, 11, and 12 were eachmoistened with 25 mL of Formulations 15 and 16. Each wipe was placedinto a borosilicate 500 mL media bottle, capped tightly, and autoclavedin a Getinge steam sterilizer with liquid cycle at 121° C. for 30 min.Upon completion of the cycle, the bottle was cooled down to roomtemperature before handling. Each wipe was folded to 1/12 of itsoriginal size and fixed with a rubber band. The wipe was set in a moldwith the upper mold box containing the wipe and lower mold box holdingthe squeezed-out liquid. A 500 lbf loading force was applied on thefolded wipe with a compression speed of 2 inches/min and held for 10seconds before releasing. All the liquid squeezed out was collected inthe lower box and disposed of after every squeezing application. Themass of each wipe was recorded before and after squeezing. The resultsare reported in Table 16 below.

TABLE 16 Squeeze Volumes pre/post Sterilization Wipe Example No. 1 11 127 3 8 pre-sterilization (F16) 17.8 16.65 16.72 16.44 17.55 16.94pre-sterilization (F15) 16.11 15.54 16.5 16.06 17.48 15.59post-sterilization (F16) 5.04 7.015 6.85 7.555 8.28 3.71post-sterilization (F15) 11.98 12.955 13.805 10.57 11.55 7.23

All reported values are grams of liquid (original soaked weight minusfinal weight after squeezing).

The squeezing volume in Table 16 is provided for the wipes of Examples1, 3, 7, 8, 11, and 12, moistened with either 0.5% Kolliphor™ RH 40(F16) or 1% Kolliphor™ RH 40 (F15) under pre-and post-heat treatmentconditions. Formulation 15 has higher surfactant concentration with 1%Kolliphor™ RH 40 and 0.125% Nonoxynol-9 than Formulation 16, which has0.5% Kolliphor™ RH 40 and 0.06% Nonoxynol-9. Prior to heat treatment,there is no significant difference in squeezing volume between the wipesof Examples 1, 3, 7, 8, 11, and 12. There was also no significantdifference between formulations F15 and 16; however, heat treatmentwithin the autoclave shrinks the polyester wipe by about 1.5-3%. Withoutbeing bound by theory, it is believed that shrinkage after heattreatment lowered the average pore size of the wipe, thus increased thecapillary pressure (capillary pressure is the force necessary to squeezea droplet through a pore and is higher for smaller pore diameter) of thesolution spread in the wipe, leading to a lowered squeezing volume forthe wipes under compression. Post-autoclave treatment, wipes moistenedwith higher surfactant (F15) delivered a much higher squeezing volumethan wipes with formulation F16 and the wipes of Examples 1, 3, 7, 8,11, and 12 delivered a significantly lower squeezing volume than allother wipe materials. Changing wipe density, fiber length or fiberdenier to increase or decrease the average pore size of the wipe is apossible approach to adjust the squeezing volume of the wipe. Based onthese results, longer fibers, larger fiber denier and higher fiberdensity appear to result in a wipe with smaller pore size, which in turnleads to a larger formulation holding volume for the wipe and a lowersqueezing volume. Increasing the surfactant concentration will also helpwith wetting the wipes. The same characteristics are found followingheat treatment in that the squeezing volume is increased with greatersurfactant concentration.

Additional data samples were collected in which the Kolliphor™ RH 40 inFormulations 15 and 16 was replaced with the same amount of polysorbate20 (i.e., 1.0% w/v polysorbate 20 and 0.5% w/v polysorbate 20,respectively). These solutions were soaked into the wipe of Example 3.The pre and post sterilizing squeeze volumes were measured in the samemanner as described above. It was found that the heat treatment alsosignificantly lowered squeeze volume, and that increasing thepolysorbate 20 content improved the squeezing volume. The squeeze volumepre- and post-heat treated, reduced from 18.50 grams to 4.64 grams whenthe polysorbate 20 concentration was 0.5% w/v. The squeeze volume pre-and post-heat treated, reduced from 18.50 grams to 9.43 grams when thepolysorbate 20 concentration was 1.0% w/v. Thus, increasing thesurfactant concentration to 1.0% allowed for a higher squeeze volume(18.50 grams to 9.43 grams).

While aspects of the present invention have been described in connectionwith illustrative implementations, it will be understood by thoseskilled in the art that variations and modifications of the aspectsdescribed above may be made without departing from the scope hereof.Other variations will be apparent to those skilled in the art from aconsideration of the specification or from a practice along the lines asdisclosed herein.

The invention claimed is:
 1. An antiseptic formulation comprising: fromabout 0.2% w/v to about 1.0% w/v of an antiseptic agent comprisingoctenidine dihydrochloride; from about 0.1% w/v to about 5.0% w/v of afirst skin conditioner comprising glycerin; from about 0.1% w/v to about3.0% w/v of a second skin conditioner comprising 1,3-propanediol, fromabout 0.05% w/v to about 2.0% w/v of an antifoaming agent comprisingdimethicone; from about 0.1% w/v to about 5.0% w/v of a first surfactantcomprising polyoxyl 40 hydrogenated castor oil; from about 0.01% w/v toabout 0.2% w/v of a second surfactant comprising nonoxynol-9; a firstbuffer salt comprising monobasic potassium phosphate; a second buffersalt comprising dibasic sodium phosphate; and water.
 2. The antisepticformulation according to claim 1, wherein the antiseptic agent iscomprised in an amount from about 0.3% w/v to about 0.6% w/v.
 3. Theantiseptic formulation according to claim 1, wherein the first skinconditioner is comprised in an amount from about 0.1% w/v to about 3.0%w/v.
 4. The antiseptic formulation according to claim 1, wherein thesecond skin conditioner is comprised in an amount from about 1.0% w/v toabout 2.0% w/v.
 5. The antiseptic formulation according to claim 1,wherein the antifoaming agent is comprised in an amount from about 0.1%w/v to about 1.0% w/v.
 6. The antiseptic formulation according to claim1, wherein the antifoaming agent is an emulsion containing 35%dimethicone.
 7. The antiseptic formulation according to claim 1, whereinthe first surfactant is comprised in an amount from about 0.5% w/v toabout 3.0% w/v.
 8. The antiseptic formulation according to claim 1,wherein the second surfactant is comprised in an amount from about 0.05%w/v to about 0.125% w/v.
 9. The antiseptic formulation according toclaim 1, wherein the first buffer salt is comprised in an amount ofabout 0.62% w/v.
 10. The antiseptic formulation according to claim 1,wherein the second buffer salt is comprised in an amount of about 0.06%w/v.
 11. A wipe comprising the antiseptic formulation according toclaim
 1. 12. The wipe according to claim 11 comprising a first fiberhaving a first denier and a second fiber having a second denier, whereinthe first denier is different from the second denier.
 13. The wipeaccording to claim 12 further comprising a third fiber having a thirddenier, wherein the third denier is different from the first denier andthe second denier.
 14. A package containing the wipe of claim 11,wherein the package comprises a metal foil or a metalized plastic. 15.An antiseptic formulation comprising: about 0.4% w/v of an antisepticagent comprising octenidine dihydrochloride; about 1.5% w/v of a firstskin conditioner comprising glycerin; about 1.5% w/v of a second skinconditioner comprising 1,3-propanediol, about 0.71% w/v of anantifoaming agent comprising an emulsion containing 35% dimethicone;about 1.0% w/v of a first surfactant comprising polyoxyl 40 hydrogenatedcastor oil; about 0.125% w/v of a second surfactant comprisingnonoxynol-9; about 0.62% w/v of a first buffer salt comprising monobasicpotassium phosphate; about 0.06% w/v of a second buffer salt comprisingdibasic sodium phosphate; and water.
 16. A wipe comprising theantiseptic formulation according to claim
 15. 17. The wipe according toclaim 16 comprising a first fiber having a first denier and a secondfiber having a second denier, wherein the first denier is different fromthe second denier.
 18. The wipe according to claim 17 further comprisinga third fiber having a third denier, wherein the third denier isdifferent from the first denier and the second denier.
 19. A packagecontaining the wipe of claim 16, wherein the package comprises a metalfoil or a metalized plastic.